Brief description of study

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and
safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFRpositive
locally advanced or metastatic urothelial carcinoma who have received Prior
platinum-containing chemotherapy.

The primary objective of the entire study is to compare rogaratinib (BAY1163877) with
chemotherapy (docetaxel, paclitaxel or vinflunine) in terms of prolonging the Overall
survival (OS) of patients with FGFR positive urothelial carcinoma.

At randomization, patients will have locally advanced or metastatic urothelial carcinoma and
have received at least one prior platinum-containing chemotherapy regimen. Only patients with
FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is
adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally
using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with
locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off
applied.